Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03024333 |
Other study ID # |
0782-16-EP |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 8, 2017 |
Est. completion date |
September 17, 2018 |
Study information
Verified date |
September 2023 |
Source |
University of Nebraska |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study is aimed to establish and identify the normal pattern of swallowing sounds and
analyze swallowing sounds of different textured foods and viscous liquids in healthy subjects
to provide clinical evidence to update dysphagia patients' food.
Description:
Upon accepted and consented, the investigators will measure the neck circumference, height
and weight of all participants. Then, a sound detection device (iASUS NT3-R Throat Mic
Headset, CA, USA) will be attached on the participant's neck. This non-invasive and
lightweight (2.3oz) device will record sound vibration signals using a pair of 20mm-diameter
sound sensors. The device will record three times of swallowing sounds at three placements
(Apleft, Apright, B) separately with participants' head-trunk in neutral position and also
record sounds in the neck such as breathing sound, throat clearing and cough sounds. (Apleft,
Apright) is the intersection of lateral border of trapezius muscle and intermediate line
between the third and fourth cervical vertebrae in the posterior neck region. B is at the
lateral cricoid cartilage in the anterolateral neck. Participants will use 5ml spoon to
intake foods or liquids at room temperature.
Healthy subjects will conduct the research in the Student Living Center Room 1036/1041 at
UNMC. Healthy subjects will be required to swallow different consistency liquids and foods
with their head-trunk in neutral position. Participants will also perform one of the
following randomly after swallowing foods or liquids: throat clearing after coughing or cough
after throat clearing. Before subjects start swallowing test, subjects can try several times
if subjects want.There will be 2 sections to complete the whole process. Each section will
take 2 hours.The device will record three times of swallowing sounds of each foods and
liquids at three placements (Apleft, Apright, B) separately with participants' head-trunk in
neutral position.The foods and liquids preparation are also listed at the end of this
section.The PI and faculty advisor of the research team will be present during recording
swallowing session.
The sound detection device will record sounds which occur in the neck such as swallowing
sounds, breathing sound, talking sounds, throat clearing and cough sounds when dysphagia
patients intake foods and drinks. The conversation will also be recorded using a Sony
recorder (ICD-SX713) in each data collection session.The voice recording will not be
analyzed, which only provides the additional information about which foods or liquids
subjects swallow or at which placement sensor records swallowing sounds. Recordings will be
saved as digital sound wave files and segmented into individual anonymized clips for data
analysis. The digital sound wave files will be achieved in the secured server at UNMC until
completion of the data analysis, and then removed from the server.
Aim1: Investigators will record the swallowing sound vibrations at the anterior and posterior
neck in healthy subjects, and analyze the duration, amplitude, mean frequency and power
spectrum of swallowing sounds generated by various viscous foods and liquids through the
pharynx.
Aim2: Investigators will compare the differences in sound duration, mean frequency and power
spectrum of swallowing sounds between throat clearing and coughing in healthy subjects.
*** *** *** *** ***
Foods and Liquids Prepared for Healthy Subjects:
Foods and liquids respectively are divided into 5 levels in the International Dysphagia Diet
Standardization Initiative (IDDSI) and level 3, 4 are two overlapping levels in foods and
drinks Level 0 (Thin liquid) All liquid can flow through syringe Level 1 (Slightly thick
liquid) There is between 1 and 4 ml remaining Level 2 (Mildly thick liquid) There is between
4 and 8 ml remaining Level 3 (Moderately thick liquid/ Liquidize) There is more than 8 ml
remaining, but some liquid still flows through Level 4 (Extremely thick liquid/ Pureed) If no
liquid flows at all Level 5 (Minced & Moist) Pressed with a fork the particles should easily
be separated between and come through the prongs of a fork Level 6 (Soft) Sample squashes and
does not return to its original shape when pressure is released.
Level 7 (Regular) No texture restrictions
Liquid Samples Preparation:
According to drink details provided in the IDDSI, investigators will choose a food
polysaccharide thickener xanthan gum (UPC784672647311, Anthony's, Gluten-Free, USA) to
prepare different viscous solutions. Firstly, dispersing xanthan gum in de-ionized water at
185 F for 10 min then carrying out solution in a 1.5 liter plastic beaker at 2000 rpm with a
four-blade propeller (60 mm in diameter) using a 6-Speed blender (XJ-14402C, Mainstays,
Walmart Inc., Bentonville, AR 72716) to ensure no lumping. After that, cool the solution to
room temperature.
Flow testing: Before flow testing, we will use 10ml water flows completely through the
syringe (A 10 ml slip tip syringe international standards (ISO 7886-1)) within 10 seconds to
check whether the nozzle is clear and free from any plastic residue or manufacturing defects
that vary occasionally occur. After checking, firstly, get a stopwatch and 2 of 10ml slip-tip
syringes. Secondly, remove the plunge from one of the syringes (Syringe A). Thirdly, cover
the nozzle of the syringe A with finger which makes a seal. Then using another syringe B to
add the syringe A up to the 10 ml line with fluid.
According to gravity flowing test, we select the following drinks. Level 0 is de-ionized
water Level 1 is xanthan gum: de-ionized water = 1oz: 5000ml Level 2 is xanthan gum:
de-ionized water = 1oz: 4000ml Level 3 is xanthan gum: de-ionized water = 1oz: 3000ml Level 4
is xanthan gum: de-ionized water = 1oz: 1000ml
Food Samples Preparation:
Fork Testing: The slots/gaps between prongs of a standard metal fork are typically in 4 mm.
Pressure applied to the food sample is quantified by assessment of the pressure needed to
make the thumb nail blanch noticeably to white color.
According to food details provided in IDDSI, we will use IDDSI Flow Test (Syringe Test), Fork
(The slots/gaps between the tines/prongs of a standard metal fork typically measure 4 mm)
Drip Test and Fork Pressure Test selects food as follows:
Level 5 (Minced & Moist) cereal: de-ionized water = 2:1 Dispersing xanthan gum in de-ionized
water at 185 F for 10 min then carrying out solution in a 1.5-liter plastic beaker at 2000
rpm with a four-blade propeller (60 mm in diameter) using a 6-Speed blender to ensure cereal
is fully moist & minced and less than 1.5cm*1.5cm. After that, cool the solution to room
temperature.
Level 6 (Soft) Banana Level 7 (Regular) White bread